AccurEdit is dedicated to advancing innovative therapies for patients with serious or life-threatening diseases. Our primary focus is to ensure the safety and efficacy of investigational products through rigorously designed clinical trials, which remain the most appropriate pathway for accessing our therapies.

Expanded access, also referred to as compassionate use, is a regulatory pathway that allows patients with serious or immediately life-threatening conditions to access investigational therapies outside of clinical trials when no comparable or satisfactory treatment options are available. The U.S. Food and Drug Administration (FDA) outlines key criteria for expanded access, including:

The patient’s condition must be serious or life-threatening, with no approved or alternative therapies.

Potential benefits of the investigational therapy must outweigh foreseeable risks, based on available safety and efficacy data.

Granting expanded access must not compromise ongoing clinical trials, regulatory submissions, or the ability to develop therapies for broader patient populations.

AccurEdit understands and appreciates this pathway and these key criteria. However, at this time, AccurEdit is not offering expanded access to our investigational therapies in the US. We regard participation in clinical trials as the preferred route for our potential patients to access investigational therapies, as these trials are carefully designed and rigorously monitored, and will generate critical data to evaluate safety and efficacy of our investigational product. We encourage patients and physicians to explore enrollment opportunities via ClinicalTrials.gov.

We recognize the urgency faced by patients with limited treatment options and the needs to balance that with safety and efficacy. We will regularly reassess this policy as clinical development progresses and regulatory landscapes evolve.

ClinicalTrials.govAs authorized by the 21st Century Cures Act, AccurEdit reserves the right to revise this policy at any time.